FDA — authorised 6 April 1982
- Marketing authorisation holder: PFIZER
- Status: approved
🇺🇸 Feldene in United States
FDA authorised Feldene on 6 April 1982
Marketing authorisations
FDA — authorised 12 March 1993
- Application: ANDA073536
- Marketing authorisation holder: SUN PHARM INDUSTRIES
- Local brand name: PIROXICAM
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 28 January 1994
- Application: ANDA073638
- Marketing authorisation holder: TEVA
- Local brand name: PIROXICAM
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 28 January 1994
- Application: ANDA073637
- Marketing authorisation holder: TEVA
- Local brand name: PIROXICAM
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 16 May 1996
- Application: ANDA074287
- Marketing authorisation holder: WATSON LABS
- Local brand name: PIROXICAM
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 9 September 2016
- Application: ANDA207938
- Marketing authorisation holder: FLAMINGO PHARMS
- Local brand name: PIROXICAM
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 13 April 2017
- Application: ANDA208340
- Marketing authorisation holder: UNICHEM
- Local brand name: PIROXICAM
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 26 January 2018
- Application: ANDA210347
- Marketing authorisation holder: STRIDES PHARMA
- Local brand name: PIROXICAM
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 21 February 2018
- Application: ANDA208991
- Marketing authorisation holder: BRECKENRIDGE
- Local brand name: PIROXICAM
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 17 July 2018
- Application: ANDA205585
- Marketing authorisation holder: ZYDUS LIFESCIENCES
- Local brand name: PIROXICAM
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA073651
- Marketing authorisation holder: CYCLE
- Local brand name: PIROXICAM
- Indication: CAPSULE — ORAL
- Status: approved
Feldene in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Immunology approved in United States
Frequently asked questions
Is Feldene approved in United States?
Yes. FDA authorised it on 6 April 1982; FDA authorised it on 12 March 1993; FDA authorised it on 28 January 1994.
Who is the marketing authorisation holder for Feldene in United States?
PFIZER holds the US marketing authorisation.